Effects of 2006-RD-05 on Salivary and Serum Immunoglobulin A (IgA) Levels in Healthy Subjects

innoVactiv Inc.50 enrolled

Overview

It is already known from animal studies that the study drug can improve mucosal immunity as shown by increased serum and mucosal IgA secretion. This study will evaluate the safety of an oral intake of the natural product 2006-RD-05 at the recommended daily dose of 300 mg. In addition, this trial will aim to determine if this intake is able ot improve serum and salivary IgA synthesis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

2006-RD-05DIETARY_SUPPLEMENT

300 mg daily, once a day for 28 consecutive days

PlaceboDIETARY_SUPPLEMENT

Capsule similar in shape, weight and color from active, once a day for 28 consecutive days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Men or women aged 18 - 60 * In good health * BMI between 20 and 30 kg/m2 * Non-smoking Exclusion Criteria: * Allergic to study drug * Use of immune-modulating drugs * Uncontrolled hypertension (Systolic \> 140 or diastolic \> 90) * Women of childbearing age not using proper contraception, that is pregnant or breastfeeding

Locations (1)

Institut des Nutraceutiques et des Aliments Fonctionnels (INAF)

Québec, Quebec, Canada

Outcomes

Primary Outcomes

Occurrence of adverse events

Time frame: Baseline, 14 days, 28 days

Secondary Outcomes

Serum IgA titers

Time frame: Baseline, 14 days, 28 days

Salivary IgA titers

Time frame: Baseline, 14 days, 28 days

Data from ClinicalTrials.gov

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